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Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

NCT00115804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-02-10

Study results available
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Summary

The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).

Conditions

  • Juvenile Primary Fibromyalgia Syndrome (JPFS)
  • Fibromyalgia

Interventions

DRUG

Fluoxetine

Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Lesley M Arnold, M.D. · Women's Health Research Program

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115804 on ClinicalTrials.gov